The present invention relates generally to a pprt and closure assembly.
Ports are utilized to provide a method for accessing material packaged within a container. As used herein, the term "ports" includes, without limitation, fitments, valves, and other means for accessing a container. In the medical industry, parenteral and peritoneal dialysis solutions, for example, are packaged in flexible containers that are accessed via a port. An example of such a flexible container is the VIAFLEX collapsible plastic container sold by Baxter Healthcare Corporation of Deerfield, Ill.
In the medical industry particularly, and other applications, it is essential that the solution in the container is maintained and extracted under sterile conditions. This requires not only that the container and its contents remain in a sterile sealed condition at the time of receipt by the user, but also that no contamination of the contents occur when the container is opened by the user.
Typically, the port comprises a tubular structure with an inner bore that extends from a base. Located within the inner bore is a pierceable wall that provides a barrier between the fluid contained within the container and the outside environment. Usually, pointed means that pierce the pierceable wall are used to gain access to the fluid and thereby the container. To protect against contamination at the port exit, closures are utilized to cover the tubular bore of the port.
Some of the prior art closures have not been entirely satisfactory. Some of the problems experienced by the prior closures are the fact that they do not provide a hermetic seal, are difficult to remove, and do not lend themselves to high speed production. Furthermore, there is also the problem that the closure must be adequately secured to the port so that it does not fall off during transportation or prior to the time one desires to access the container.
Furthermore, some of the closures of the prior art have not been entirely satisfactory because they do not provide a tamper evident closure. Because it is critical that a sterile environment is maintained, it is advantageous that the closure and port cooperate to provide some means for alerting the user that the closure has been opened and accordingly, the aseptic environment violated.
A further problem with some prior art closures, is the fact that they typically cannot be used to identify the solution contained within the container once the closure is opened. To identify the type of solution contained in a container, closures may be color coded. But, once the closure is removed from the port, the container is no longer coded.
Thus, there is a need for a port and closure assembly that overcomes some of the disadvantages of the prior art.